Regulatory Affairs Senior Manager

Location:
Hertfordshire
Sector:
Management
Job Type:
Temporary
Salary range:
Other
Salary:
£114,400 to £133,120 per annum
Salary:
£55 - £64 per hour
Posted:
30-Jul-18
Start Date:
Recruiter:
Uxbridge Employment Agency
Job Ref:
888408

Regulatory Affairs Senior Manager

To start ASAP

Reporting to: Executive Director, European Regulatory Affairs (Non Oncology)

This role will support one or more products from a regional regulatory perspective.

As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling

by developing and executing regional regulatory strategies

and managing effective agency interactions.

Job Summary

Ensure business acquires and maintains all the

required licenses in order to support clinical trials

To ensure regulatory compliance, with a focus on patient

safety

Plans and manages regulatory submissions (e.g. clinical trial

and marketing applications)

Implements product related regulatory strategies,

• Leads development of regional regulatory documents and

meetings

• Provides regulatory direction on regional regulatory

mechanisms

• Directs the development of the regional product label by

collaborating with the Labelling

• Manages regional label negotiation activities

• Obtains and maintains Clinical Trial Authorizations and

Marketing Application approvals

• Communicates regulatory strategies as appropriate such

that expectations are understood.

• Develop predictions for expectations and risks associated

with outcomes by regulatory agencies

• Partner with regional management and peers to ensure

consistency in procedures and agency interactions

• Regulatory Research

• Maintains an awareness of new and developing legislation,

regulatory policy and technical Regulatory guidance

• Health Authority Interactions

Knowledge and Skills

• Regulatory knowledge in national regulations

• Working with policies, procedures and SOP’s

• Experience with national legislation and regulations

relating to medicinal products

• Understanding of drug development

• Team work

• Negotiation skills

• Good communication skills - both oral and written

• Ability to understand and communicate scientific/clinical

information

• Ability to anticipate and prevent potential issues

• Communication of regulatory strategies such that

expectations are understood.

• Anticipate regulatory agency responses to strategy

• Strong knowledge of and experience in regional regulatory

environment in relevant product area and development

stage

• Comprehensive understanding of regulatory activities,

touch points and how they affect projects and processes

• Ability to resolve conflicts and develop a course of action

leading to a beneficial outcome

• Cultural awareness and sensitivity to achieve results across

both regional country and International borders

------------------------------------------------------------------------------------
We are an independent recruitment agency who are celebrating our 40th year of supporting local candidates find local opportunities. Based centrally in both Uxbridge & Windsor we offer permanent, temporary and contract recruitment services within Middlesex, Buckinghamshire, Berkshire and the West London region.

For the purpose of the Conduct Regulations please be advised that when advertising permanent vacancies we are acting as an Employment Agency and when advertising temporary/contract vacancies we are acting as an Employment Business.

We take your personal data seriously and take every step to protect it. To lear

Contact Details:
Uxbridge Employment Agency
Tel: 01895 520 700
Contact: Claire Jordan
Email:

Return to search results

X
Latest Job Listings